Status:
COMPLETED
Prone-Supine Study II: The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome
Lead Sponsor:
Policlinico Hospital
Conditions:
ARDS, Human
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether prone positioning is effective in improving survival in patients affected by acute respiratory distress syndrome (ARDS).
Detailed Description
BACKGROUND: The beneficial effect of prone positioning on arterial oxygenation has been well demonstrated in ALI/ARDS patients. Moreover prone positioning has an impact on the distribution of the lung...
Eligibility Criteria
Inclusion
- Patients receiving mechanical ventilation will be enrolled if they meet criteria for acute respiratory distress syndrome, with the PaO2/FiO2 ratio criterion modified as follows:
- PaO2/FiO2 ratio ≤ 200 with 5 ≤ PEEP ≤ 10 cmH2O
Exclusion
- Age \< 16 years.
- \> 72 hours since all inclusion criteria are met.
- Lung transplant, liver transplant or bone marrow transplant.
- Clinical or instrumental evidence of cerebral edema or elevated endocranial pressure.
- Conditions which are thought to contraindicate the use of prone positioning (i.e., not-stabilized bone fracture, column fracture, pelvis fracture, multiple rib fracture with chest-wall instability, severe haemodynamic instability).
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00159939
Start Date
February 1 2004
End Date
June 1 2008
Last Update
June 11 2008
Active Locations (17)
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1
Hospital "Ospedali Riuniti di Bergamo"
Bergamo, Italy
2
Hospital "Ospedale Maggiore di Bologna"
Bologna, Italy
3
Hospital "di Circolo"
Busto Arsizio, Italy
4
Hospital "A.Uboldo"
Cernusco sul Naviglio, Italy